Patient has more than 2 episode of awakening to void during normal sleeping hours.

Patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics) known to affect lower urinary tract function, including but not limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers, for at least 2 weeks prior to randomization or is likely to change during the course of the study.

Patient is pregnant, lactating, or plans to become pregnant during the course of the study.

Patient refuses to provide written informed consent.

Patient is not at least 18 years of age.

Patient is not available for the follow-up evaluations as required by the protocol.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382602